Last update 07 Dec 2024
NI-0101
Last update 07 Dec 2024
Overview
Basic Info
Drug Type Monoclonal antibody |
Synonyms paridiprubart, EB 05, EB-05 + [1] |
Target |
Mechanism TLR4 antagonists(Toll like receptor 4 antagonists) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization- |
Drug Highest PhasePhase 3 |
First Approval Date- |
RegulationFast Track (US) |
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Gene Sequence
Sequence Code 13017822L
Source: *****
Sequence Code 1038074631H
Source: *****
Related
7
Clinical Trials associated with NI-0101Phase 2 Clinical Platform Trial Investigating Multiple Therapeutic Options for the Treatment of Hospitalized Patients with Acute Respiratory Distress Syndrome (ARDS)
This is a Phase 2 multicenter, randomized, double-blinded, placebo-controlled study that will evaluate the safety and efficacy of host-directed therapeutics in hospitalized adults diagnosed with Acute Respiratory Distress Syndrome (ARDS) utilizing a platform trial design.
Cohort B: Participants will be randomized to receive either a placebo or paridiprubart.
This record describes the default procedures and analyses for Cohort B. Please see NCT06703073 for information on the BP-ARDS-P2-001 Master Protocol.
Cohort B: Participants will be randomized to receive either a placebo or paridiprubart.
This record describes the default procedures and analyses for Cohort B. Please see NCT06703073 for information on the BP-ARDS-P2-001 Master Protocol.
Start Date06 Jan 2025 |
Sponsor / Collaborator PPD Development LP [+4] |
Phase 2 Clinical Platform Trial Investigating Multiple Therapeutic Options for the Treatment of Hospitalized Patients with Acute Respiratory Distress Syndrome (ARDS)
This is a Phase 2 multicenter, randomized, double-blinded, placebo-controlled study that will evaluate the safety and efficacy of host-directed therapeutics in hospitalized adults diagnosed with Acute Respiratory Distress Syndrome (ARDS) utilizing a platform trial design. Participants will be randomized to receive either a placebo or one of the active treatments.
This record describes the default procedures and analyses for all cohorts. Each specific cohort may have additional eligibility requirements, safety and efficacy procedures, or endpoints, which will be described in the corresponding intervention-specific records on clinicaltrials.gov listed below in the detailed description.
This record describes the default procedures and analyses for all cohorts. Each specific cohort may have additional eligibility requirements, safety and efficacy procedures, or endpoints, which will be described in the corresponding intervention-specific records on clinicaltrials.gov listed below in the detailed description.
Start Date20 Dec 2024 |
Sponsor / Collaborator PPD Development LP [+4] |
A randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of EB05 + SOC vs. placebo + SOC in adult hospitalized patients with COVID19
Start Date25 Oct 2021 |
Sponsor / Collaborator- |
100 Clinical Results associated with NI-0101
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100 Translational Medicine associated with NI-0101
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100 Patents (Medical) associated with NI-0101
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8
Literatures (Medical) associated with NI-010101 Mar 2020·Annals of the rheumatic diseasesQ1 · MEDICINE
Efficacy and safety of NI-0101, an anti-toll-like receptor 4 monoclonal antibody, in patients with rheumatoid arthritis after inadequate response to methotrexate: a phase II study
Q1 · MEDICINE
Article
Author: Choy, Ernest H ; McInnes, Iain ; Jacqmin, Philippe ; Lapeyre, Geneviève ; de Min, Cristina ; Kobakhidze, Tamta ; de Graaf, Kathy ; Monnet, Emmanuel
Objectives:
Anti-citrullinated protein antibodies (ACPAs) form immune complexes with citrullinated proteins binding toll-like receptor (TLR) 4, which has been proposed as a mediator of rheumatoid arthritis (RA). NI-0101 is a first-in-class humanised monoclonal antibody blocking TLR4, as confirmed by inhibition of in vivo lipopolysaccharide-induced cytokine release in healthy volunteers. This study was design to confirm preclinical investigations supporting a biomarker-driven approach for treatment of patients with RA who present positive for these immune complexes.
Methods:
Placebo-controlled, double-blind, randomised (2:1) trial of the tolerability and efficacy of NI-0101 (5 mg/kg, every 2 weeks for 12 weeks) versus placebo in ACPA-positive RA patients with inadequate response to methotrexate. Efficacy measures included Disease Activity Score (28-joint count) with C reactive protein (DAS28-CRP), European League Against Rheumatism (EULAR) good and moderate responses, and American College of Rheumatology (ACR) 20, ACR50 and ACR70 responses. Subgroup analyses defined on biomarkers were conducted. Pharmacokinetics, pharmacodynamics and safety were reported.
Results:
90 patients were randomised (NI-0101 (61) and placebo (29)); 86 completed the study. No significant between-group difference was observed for any of the efficacy endpoints. Subgroup analyses using baseline parameters as covariants did not reveal any population responding to NI-0101. Treatment-emergent adverse events occurred in 51.7% of patients who received placebo versus 52.5% for NI-0101.
Conclusions:
We demonstrate for the first time that in RA, a human immune-mediated inflammatory disease, blocking the TLR4 pathway alone does not improve disease parameters. Successful targeting of innate immune pathways in RA may require broader and/or earlier inhibitory approaches.
01 Nov 2017·Pharmacotherapy
Pharmacovigilance Assessment of Immune‐Mediated Reactions Reported for Checkpoint Inhibitor Cancer Immunotherapies
Article
Author: Watson, David E. ; Ali, Ayad K.
Study Objective:
Ipilimumab, pembrolizumab, and nivolumab are checkpoint inhibitors (CPIs) that activate T‐cell–mediated immune response. CPI can provide durable benefits to some cancer patients with melanoma, renal cell cancer, non–small cell lung cancer, or a growing list of other cancers. However, CPI treatment is also associated with adverse immune‐mediated reactions (IMRs) that can be life‐threatening. This pharmacovigilance analysis aims to characterize IMR signals in relation to CPI treatment.
Design:
Retrospective pharmacovigilance disproportionality analysis.
Data Source:
U.S. Food and Drug Administration Adverse Event Reporting System (FAERS).
Measurements and Main Results:
Adverse event reports submitted to FAERS between 2011 and 2015 were analyzed. CPIs were identified by generic names, and IMRs were identified by MedDRA Preferred Terms. Empirical Bayes geometric means with corresponding 95% confidence intervals (EB05‐EB95) were calculated as CPI‐IMR association metrics. Signals were defined as metrics with EB05 ≥ 2.0. Overall, 1,018 IMR events were submitted for CPIs, corresponding to 76% for ipilimumab, 15% for nivolumab, and 9% for pembrolizumab. The period of data collection precluded data on the most recently approved CPI agents. IMRs consisted of 51% colitis, 16% endocrinopathies, 12% pneumonitis, 11% hepatitis, 4% infusion‐related reactions, 3% nephritis, and 3% other IMRs. Colitis contributed to 63% and 41% of IMRs for ipilimumab and nivolumab, respectively. Pneumonitis and hepatitis contributed to a majority of IMRs for pembrolizumab, for which nephritis and infusion‐related reactions were not reported. Signals of IMRs were detected for CPIs as a class (EB05 = 12.4) and individual agents: ipilimumab (EB05 = 13.2), nivolumab (EB05 = 15.0), and pembrolizumab (EB05 = 7.3). Colitis and pneumonitis had the strongest signals for CPIs (EB05 = 45.6 and EB05 = 17.6, respectively). Colitis was the strongest signal for ipilimumab (EB05 = 54.2), and pneumonitis was the strongest signal for nivolumab (EB05 = 48.0) and pembrolizumab (EB05 = 21.8).
Conclusion:
Cancer immunotherapy with CPIs is associated with a multitude of IMRs, especially colitis and pneumonitis. Individual CPIs had variable IMR signals, and pharmacoepidemiologic studies are required to evaluate the identified signals.
01 Feb 2017·Clinical pharmacology and therapeuticsQ2 · MEDICINE
Evidence of NI‐0101 pharmacological activity, an anti‐TLR4 antibody, in a randomized phase I dose escalation study in healthy volunteers receiving LPS
Q2 · MEDICINE
Article
Author: Min, C de ; Poelgeest, E van ; Monnet, E ; Graaf, K de ; Jacqmin, P ; Moerland, M ; Burggraaf, J ; Reijers, J ; Lapeyre, G
Toll‐like receptor‐4 (TLR4) pathways are major contributors to pathological inflammatory responses induced by tissue damage. NI‐0101 is the first monoclonal antibody (mAb) blocking TLR4 signaling. This activity is independent of the ligand type and concentration, therefore, potentially blocking any TLR4 ligands. A phase I single ascending dose study was conducted in 73 healthy volunteers to evaluate NI‐0101 tolerability, preliminary safety, pharmacokinetics (PKs), and pharmacodynamics (PDs), in absence and in presence of a systemic challenge with lipopolysaccharide (LPS), a TLR4 ligand. NI‐0101 was well tolerated without safety concern. The PK profile was characterized by a half‐life of ∼10 days at high concentrations and by a rapid elimination at low concentrations due to expected target‐mediated drug disposition. NI‐0101 prevented cytokine release following ex vivo and in vivo LPS administration and prevented the C‐reactive protein (CRP) increase and the occurrence of flu‐like symptoms expected following the in vivo administration of LPS.
42
News (Medical) associated with NI-010131 Oct 2024
TORONTO, Oct. 31, 2024 (GLOBE NEWSWIRE) -- Edesa Biotech, Inc. (Nasdaq:EDSA), a clinical-stage biopharmaceutical company focused on developing host-directed therapeutics for immuno-inflammatory diseases, today announced that the company has entered into a purchase agreement with an entity affiliated with Par Nijhawan, MD, Edesa’s Chief Executive Officer and Founder, to invest up to $5.0 million in the company, including an immediate investment of approximately $1.5 million. The entity will purchase shares of the company’s Series A-1 Convertible Preferred Shares, as amended (the “Series A-1 Preferred Shares”), having a stated value of $10,000 per share, and warrants (the “Warrants”) to purchase the company’s common shares in a transaction structured as an at-the-market issuance under Nasdaq rules. The Series A-1 Preferred Shares will be convertible into the company’s common shares at a conversion price of $3.445. The Warrants will be exercisable for a number of common shares equal to 75% of the common shares initially issuable upon the conversion of the Series A-1 Preferred Shares. Commenting on today’s announcement, Dr. Nijhawan said “I am pleased to demonstrate my strong belief in Edesa’s future growth opportunities and my continuing commitment to lead the company’s strategic initiatives. I believe Edesa has a strong development pipeline, and I am confident that we can continue to build on our operational and clinical success.” Subject to certain exceptions and adjustments for share splits, each Series A-1 Preferred Share is convertible into a number of Edesa’s common shares calculated by dividing (i) the sum of the stated value of the Series A-1 Shares being converted plus a return equal to 10% of such stated value per annum by (ii) the conversion price. The Warrants will have an exercise price of $3.445 per share, will be exercisable immediately upon issuance and will expire five years from the date of issuance. Under applicable Canadian securities laws, purchases of Series A-1 Preferred Shares under the purchase agreement in an aggregate amount greater than $2.0 million will be subject to the prior approval of the company’s shareholders, excluding Dr. Nijhawan. The company also announced that in connection with the transactions contemplated by the purchase agreement, the $10 million revolving credit agreement previously entered into with the purchaser has been terminated. The company did not draw any funds from the facility. The securities described above have not been and will not be registered under the Securities Act of 1933, as amended, and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements. About Edesa Biotech, Inc. Edesa Biotech, Inc. (Nasdaq: EDSA) is a clinical-stage biopharmaceutical company developing innovative ways to treat inflammatory and immune-related diseases. Its clinical pipeline is focused on two therapeutic areas: Medical Dermatology and Respiratory. In Medical Dermatology, Edesa is developing EB06, an anti-CXCL10 monoclonal antibody candidate, as therapy for vitiligo, a common autoimmune disorder that causes skin to lose its color in patches. Its medical dermatology assets also include EB01 (1.0% daniluromer cream), a Phase 3-ready asset developed for use as a potential therapy for moderate-to-severe chronic Allergic Contact Dermatitis (ACD), a common occupational skin condition. The company’s most advanced Respiratory drug candidate is EB05 (paridiprubart), which is being evaluated in a U.S. government-funded platform study as a treatment for Acute Respiratory Distress Syndrome (ARDS), a life-threatening form of respiratory failure. The EB05 program has been the recipient of two funding awards from the Government of Canada to support the further development of this asset. In addition to EB05, Edesa is preparing an investigational new drug application (IND) in the United States for EB07 (paridiprubart) to conduct a future Phase 2 study in patients with pulmonary fibrosis. Sign up for news alerts. Connect with us on X and LinkedIn. Edesa Forward-Looking StatementsThis press release may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by the use of words such as "anticipate," "believe," "plan," "estimate," "expect," "intend," "may," "will," "would," "could," "should," "might," "potential," or "continue" and variations or similar expressions, including statements related to: the company’s belief that Dr. Nijhawan’s investment is strategic and demonstrates a strong belief in Edesa’s future growth opportunities and a continuing commitment to lead the company’s strategic initiatives; the company’s belief that it has a strong development pipeline; the company’s confident belief that it can continue to build on its operational and clinical success; and the company's timing and plans regarding its clinical studies in general. Readers should not unduly rely on these forward-looking statements, which are not a guarantee of future performance. There can be no assurance that forward-looking statements will prove to be accurate, as all such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results or future events to differ materially from the forward-looking statements. Such risks include: the ability of Edesa to obtain regulatory approval for or successfully commercialize any of its product candidates, the risk that access to sufficient capital to fund Edesa's operations may not be available or may be available on terms that are not commercially favorable to Edesa, the risk that Edesa's product candidates may not be effective against the diseases tested in its clinical trials, the risk that Edesa fails to comply with the terms of license agreements with third parties and as a result loses the right to use key intellectual property in its business, Edesa's ability to protect its intellectual property, the timing and success of submission, acceptance and approval of regulatory filings, and the impacts of public health crises. Many of these factors that will determine actual results are beyond the company's ability to control or predict. For a discussion of further risks and uncertainties related to Edesa's business, please refer to Edesa's public company reports filed with the U.S. Securities and Exchange Commission and the British Columbia Securities Commission. All forward-looking statements are made as of the date hereof and are subject to change. Except as required by law, Edesa assumes no obligation to update such statements.
Phase 2
21 Oct 2024
TORONTO, Oct. 21, 2024 (GLOBE NEWSWIRE) -- Edesa Biotech, Inc. (Nasdaq:EDSA), a clinical-stage biopharmaceutical company focused on developing host-directed therapeutics for immuno-inflammatory diseases, announced today that Edesa management and business development staff plan to participate in the following upcoming conferences: BIO-Europe, Stockholm, Sweden, November 4-6, 2024Dermatology Drug Development Summit, Boston, Mass., November 12-14, 2024LSX Investival Showcase, London, UK, November 18, 2024 To schedule a meeting with Edesa during the conferences, please contact conference organizers or the company directly at investors@edesabiotech.com. About Edesa Biotech, Inc. Edesa Biotech, Inc. (Nasdaq: EDSA) is a clinical-stage biopharmaceutical company developing innovative ways to treat inflammatory and immune-related diseases. Its clinical pipeline is focused on two therapeutic areas: Medical Dermatology and Respiratory. In Medical Dermatology, Edesa is developing EB06, an anti-CXCL10 monoclonal antibody candidate, as therapy for vitiligo, a common autoimmune disorder that causes skin to lose its color in patches. Its medical dermatology assets also include EB01 (1.0% daniluromer cream), a Phase 3-ready asset developed for use as a potential therapy for moderate-to-severe chronic Allergic Contact Dermatitis (ACD), a common occupational skin condition. The company’s most advanced Respiratory drug candidate is EB05 (paridiprubart), which is being evaluated in a U.S. government-funded platform study as a treatment for Acute Respiratory Distress Syndrome (ARDS), a life-threatening form of respiratory failure. The EB05 program has been the recipient of two funding awards from the Government of Canada to support the further development of this asset. In addition to EB05, Edesa is preparing an investigational new drug application (IND) in the United States for EB07 (paridiprubart) to conduct a future Phase 2 study in patients with pulmonary fibrosis. Sign up for news alerts. Connect with us on X and LinkedIn. Edesa Forward-Looking Statements This press release may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by the use of words such as "anticipate," "believe," "plan," "estimate," "expect," "intend," "may," "will," "would," "could," "should," "might," "potential," or "continue" and variations or similar expressions. Readers should not unduly rely on these forward-looking statements, which are not a guarantee of future performance. There can be no assurance that forward-looking statements will prove to be accurate, as all such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results or future events to differ materially from the forward-looking statements. Such risks include: the ability of Edesa to obtain regulatory approval for or successfully commercialize any of its product candidates, the risk that access to sufficient capital to fund Edesa's operations may not be available or may be available on terms that are not commercially favorable to Edesa, the risk that Edesa's product candidates may not be effective against the diseases tested in its clinical trials, the risk that Edesa fails to comply with the terms of license agreements with third parties and as a result loses the right to use key intellectual property in its business, Edesa's ability to protect its intellectual property, the timing and success of submission, acceptance and approval of regulatory filings, and the impacts of public health crises. Many of these factors that will determine actual results are beyond the company's ability to control or predict. For a discussion of further risks and uncertainties related to Edesa's business, please refer to Edesa's public company reports filed with the U.S. Securities and Exchange Commission and the British Columbia Securities Commission. All forward-looking statements are made as of the date hereof and are subject to change. Except as required by law, Edesa assumes no obligation to update such statements. Contact:Gary KoppenjanEdesa Biotech, Inc. (289) 800-9600investors@edesabiotech.com
Phase 2
09 Aug 2024
TORONTO, Aug. 09, 2024 (GLOBE NEWSWIRE) -- Edesa Biotech, Inc. (Nasdaq:EDSA), a clinical-stage biopharmaceutical company focused on developing host-directed therapeutics for immuno-inflammatory diseases, today reported financial results for the three and nine months ended June 30, 2024 and provided an update on its business. During the quarter, the company’s anti-TLR4 drug candidate, EB05 (paridiprubart), was selected by the U.S. Department of Health and Human Services for use in a U.S. government-funded platform study investigating novel threat-agnostic host-directed therapeutics in patients with Acute Respiratory Distress Syndrome (ARDS). Edesa is providing drug product for the trial as well as technical support at its own expense. In addition, the company reported today that it plans to continue utilizing its internal resources to advance its vitiligo and pulmonary fibrosis programs, including preparations to file an Investigational New Drug application with the U.S. Food and Drug Administration for a Phase 2 study of its anti-CXCL10 technology in moderate-to-severe vitiligo patients. “We believe the fully funded government ARDS clinical study has the potential to open significant new value-creation opportunities for Edesa,” said Par Nijhawan, MD, Chief Executive Officer of Edesa Biotech. “This commitment to our TLR4 technology positions us to increase investment and operational focus on our other programs.” Edesa's Chief Financial Officer Stephen Lemieux reported that financial results for the three and nine months ended June 30, 2024 were in line with management’s expectations. "Our fiscal quarter and nine-month results demonstrate our commitment to prudent use of working capital and effective financial management, while we strategically advance our pipeline. We believe this steady performance enhances our position for future financing and other opportunities to support the advancement of our clinical programs,” he said. Financial Results for the Three Months Ended June 30, 2024 Total operating expenses decreased by $0.2 million to $1.9 million for the three months ended June 30, 2024 compared to $2.1 million for the same period last year. Research and development expenses decreased by $0.1 million to $0.9 million for the three months ended June 30, 2024 compared to $1.0 million for the same period last year primarily due to decreased external research expenses related to the company’s ongoing Phase 3 ARDS study and its completed dermatitis study, which were partially offset by an increase in expenses related to manufacturing of the company’s investigational drug, paridiprubart. General and administrative expenses were unchanged at $1.0 million for the three months ended June 30, 2024 and June 30, 2023. Total other income increased by $185,000 to $264,000 for the three months ended June 30, 2024 compared to $79,000 for the same period last year primarily due to an increase in reimbursement funding from the Canadian government's Strategic Innovation Fund. For the quarter ended June 30, 2024, Edesa reported a net loss of $1.7 million, or $0.52 per common share, compared to a net loss of $2.0 million, or $0.68 per common share, for the quarter ended June 30, 2023. Financial Results for the Nine Months Ended June 30, 2024 Total operating expenses decreased by $0.9 million to $6.0 million for the nine months ended June 30, 2024 compared to $6.9 million for the same period last year: Research and development expenses decreased by $1.0 million to $2.8 million for the nine months ended June 30, 2024 compared to $3.8 million for the same period last year primarily due to decreased external research expenses related to the company’s completed dermatitis study and a reduction in noncash share-based compensation and labor costs, which were partially offset by an increase in expenses for the company’s ongoing ARDS study and expenses related to manufacturing of paridiprubart. General and administrative expenses increased by $0.2 million to $3.2 million for the nine months ended June 30, 2024 compared to $3.0 million for the same period last year primarily due to increased fees for professional services, which were partially offset by a decrease in non-cash share-based compensation. Total other income increased by $0.6 million to $0.8 million for the nine months ended June 30, 2024 compared to $0.2 million for the same period last year primarily due to an increase in reimbursement funding from the Canadian government's Strategic Innovation Fund. For the nine months ended June 30, 2024, Edesa reported a net loss of $5.2 million, or $1.64 per common share, compared to a net loss of $6.7 million, or $2.37 per common share, for the nine months ended June 30, 2023. Working Capital At June 30, 2024, Edesa had cash and cash equivalents of $2.0 million and working capital of $0.7 million. Subsequent to the quarter end, the company received $0.3 million in reimbursement funding from the Canadian government's Strategic Innovation Fund. To date, the company has not drawn any funds under a $10.0 million revolving credit agreement with the company’s founder and chief executive officer. Calendar Edesa management plans to participate in the Canaccord 44th Annual Growth Conference being held August 13-15, 2024 in Boston, Mass; the H.C. Wainwright 26th Annual Global Investment Conference being held September 9-11, 2024 in New York, NY and the Dermatology Drug Development Summit being held November 12-14, 2024 in Boston, Mass. Attendees interested in meeting with management can request meetings through the conference organizers or by contacting Edesa directly at investors@edesabiotech.com. About Edesa Biotech, Inc. Edesa Biotech, Inc. (Nasdaq: EDSA) is a clinical-stage biopharmaceutical company developing innovative ways to treat inflammatory and immune-related diseases. The company’s most advanced drug candidate is EB05 (paridiprubart), a monoclonal antibody developed for acute and chronic disease indications that involve dysregulated innate immune responses. Edesa is currently evaluating EB05 in a Phase 3 study as a potential treatment for Acute Respiratory Distress Syndrome (ARDS), a life-threatening form of respiratory failure. EB05 has also been included in a U.S. government funded platform study of host directed therapeutics. In addition, the company has received Canadian regulatory approval to conduct a Phase 2 trial its EB06 (anti-CXCL10) monoclonal antibody as a treatment for vitiligo, a life-altering autoimmune disease that causes skin to lose its color in patches. In addition, Edesa is developing an sPLA2 inhibitor, EB01 (1.0% daniluromer cream), as a topical treatment for chronic Allergic Contact Dermatitis (ACD), a common occupational skin condition. Sign up for news alerts. Connect with us on X (Twitter) and LinkedIn. Edesa Forward-Looking Statements This press release may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by the use of words such as "anticipate," "believe," "plan," "estimate," "expect," "intend," "may," "will," "would," "could," "should," "might," "potential," or "continue" and variations or similar expressions, including statements related to: Edesa plans to provide drug product and technical support for a U.S. funded ARDS study; the company’s plans to continue using internal resources to advance its vitiligo and pulmonary fibrosis programs, including preparations to file an Investigational New Drug application with the U.S. Food and Drug Administration for a Phase 2 study of its anti-CXCL10 technology in moderate-to-severe vitiligo patients; the company’s belief that the fully funded government ARDS study opens significant new value-creation opportunities for Edesa,; the company’s belief that it is now in a position to redeploy its resources for its anti-inflammatory TLR4 technology and other programs; the company’s plans to potentially place increased operational focus on vitiligo and pulmonary fibrosis areas and its belief that is significant unmet medical need and increasing industry interest in these indications; the company’s belief that its third fiscal quarter and nine month results demonstrate its commitment to prudent use of working capital and effective financial management; the company’s belief that its steady performance enhances its position for future financing and other opportunities to support the advancement of our clinical programs; the company’s plans to strategically advance its pipeline; and the company's timing and plans regarding its clinical studies in general. Readers should not unduly rely on these forward-looking statements, which are not a guarantee of future performance. There can be no assurance that forward-looking statements will prove to be accurate, as all such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results or future events to differ materially from the forward-looking statements. Such risks include: the ability of Edesa to obtain regulatory approval for or successfully commercialize any of its product candidates, the risk that access to sufficient capital to fund Edesa's operations may not be available or may be available on terms that are not commercially favorable to Edesa, the risk that Edesa's product candidates may not be effective against the diseases tested in its clinical trials, the risk that Edesa fails to comply with the terms of license agreements with third parties and as a result loses the right to use key intellectual property in its business, Edesa's ability to protect its intellectual property, the timing and success of submission, acceptance and approval of regulatory filings, and the impacts of public health crises. Many of these factors that will determine actual results are beyond the company's ability to control or predict. For a discussion of further risks and uncertainties related to Edesa's business, please refer to Edesa's public company reports filed with the U.S. Securities and Exchange Commission and the British Columbia Securities Commission. All forward-looking statements are made as of the date hereof and are subject to change. Except as required by law, Edesa assumes no obligation to update such statements. Contact:Gary KoppenjanEdesa Biotech, Inc. (289) 800-9600investors@edesabiotech.com
Condensed Interim Consolidated Statements of Operations(Unaudited)
Three Months Ended Nine Months Ended June 30, 2024 June 30, 2023 June 30, 2024 June 30, 2023
Expenses:
Research and development 897,305 1,025,622 $2,778,100 $3,841,150 General and administrative 1,035,140 1,038,587 3,232,248 3,011,945
Loss from operations (1,932,445) (2,064,209) (6,010,348) (6,853,095)
Other Income (Loss):
Reimbursement grant income 236,226 - 661,062 - Other income (loss) 28,007 79,303 142,092 199,823
Income tax expense - - 800 800
Net loss (1,668,212) (1,984,906) (5,207,994) (6,654,072)
Exchange differences on translation 1,612 39,839 (10,143) 23,415
Net comprehensive loss $(1,666,600) $(1,945,067) $(5,218,137) $(6,630,657)
Weighted average number of common shares 3,221,806 2,930,681 3,180,647 2,802,793
Loss per common share - basic and diluted $(0.52) $(0.68) $(1.64) $(2.37)
Condensed Interim Consolidated Balance Sheets(Unaudited)
June 30, 2024 September 30, 2023
Assets: Cash and cash equivalents $2,040,884 $5,361,397 Other current assets 1,005,750 1,075,455 Non-current assets 2,181,088 2,453,585
Total Assets $5,227,722 $8,890,437
Liabilities and shareholders' equity: Current liabilities $2,360,627 $1,821,864 Non-current liabilities - 19,773 Shareholders' equity 2,867,095 7,048,800
Total liabilities and shareholders' equity $5,227,722 $8,890,437 Condensed Interim Consolidated Statements of Cash Flows(Unaudited)
Nine Months Ended June 30, 2024 June 30, 2023
Cash flows from operating activities: Net loss $(5,207,994) $(6,654,072)Adjustments for non-cash items 570,636 866,881 Change in working capital items 714,192 618,730
Net cash used in operating activities (3,923,166) (5,168,461)
Net cash provided by financing activities 623,466 4,417,646
Effect of exchange rate changes on cash and cash equivalents (20,813) 117,066
Net change in cash and cash equivalents (3,320,513) (633,749)Cash and cash equivalents, beginning of year 5,361,397 7,090,919
Cash and cash equivalents, end of year $2,040,884 $6,457,170
Phase 2Financial StatementPhase 3
100 Deals associated with NI-0101
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| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Respiratory Distress Syndrome, Adult | Phase 3 | US | 11 Jul 2022 | |
| Respiratory Distress Syndrome, Adult | Phase 3 | CA | 11 Jul 2022 | |
| Respiratory Distress Syndrome, Adult | Phase 3 | CO | 11 Jul 2022 | |
| COVID-19 | Phase 3 | US | 25 Nov 2020 | |
| COVID-19 | Phase 3 | CA | 25 Nov 2020 | |
| Respiratory Distress Syndrome, Acute | Phase 3 | US | 25 Nov 2020 | |
| Respiratory Distress Syndrome, Acute | Phase 3 | CA | 25 Nov 2020 | |
| Rheumatoid Arthritis | Phase 2 | BA | 10 May 2017 | |
| Rheumatoid Arthritis | Phase 2 | BG | 10 May 2017 | |
| Rheumatoid Arthritis | Phase 2 | GE | 10 May 2017 |
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